Personalized Cell & Gene Therapies Market - Global Forecast 2026-2032

The Personalized Cell & Gene Therapies Market size was estimated at USD 10.14 billion in 2025 and expected to reach USD 11.57 billion in 2026, at a CAGR of 13.64% to reach USD 24.84 billion by 2032.

Personalized cell and gene therapies have rapidly become cornerstones in the evolution of biopharmaceutical innovation, offering the promise of one-time curative treatments for conditions that have long eluded conventional approaches. In 2025, the FDA approved Encelto, an allogeneic encapsulated cell-based gene therapy for macular telangiectasia type 2, marking a significant milestone in ocular regenerative treatments. Shortly thereafter, the U.S. cleared Zevaskyn, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa, validating the translation of cutting-edge manufacturing into life-changing therapies. These landmark regulatory successes underscore the maturation of complex biologics and the readiness of manufacturing platforms to support broader clinical applications.

Beyond regulatory approvals, the development landscape is robust and rapidly expanding. Analyses by the American Society of Gene and Cell Therapy and Citeline reveal that just over 2,000 gene therapies are at various stages of development worldwide, reflecting a dynamic pipeline poised to reshape treatment paradigms across multiple disease areas. Complementing this, clinical trial data indicate more than 450 ongoing gene therapy trials globally, a year-over-year increase driven by advances in vector design, delivery platforms, and safety monitoring. Together, these metrics illustrate a field in the midst of exponential growth, heralding a future in which personalized interventions address previously intractable diseases.

Scientific and technological breakthroughs are redefining the boundaries of what is possible in cell and gene therapy. Recent advances in gene editing tools such as CRISPR and base editors are enabling precise modifications of disease-causing genetic lesions, while non-viral delivery systems, including lipid nanoparticles and improved adeno-associated viral vectors, are expanding the safety profile and tissue reach of in vivo approaches. Concurrently, allogeneic cell therapy platforms, leveraging induced pluripotent stem cells and engineered immune cells, are emerging as scalable alternatives to traditional autologous constructs, offering the potential for off-the-shelf availability without compromising efficacy.

Regulatory frameworks have evolved in parallel to support these innovations. In June 2025, the FDA eliminated Risk Evaluation and Mitigation Strategies (REMS) requirements for approved CAR-T therapies, recognizing the established safety profiles and shifting the focus toward broader patient access for treatments such as Breyanzi, Kymriah, and Yescarta. Moreover, the cumulative number of RMAT designation requests reached 71 by mid-2025, with 41 designations granted, reflecting accelerated development pathways for regenerative medicine candidates. Such targeted regulatory support, combined with streamlined review processes, has catalyzed a surge in early-stage programs and drawn strategic partnerships between biotech innovators and established pharma leaders.

Proposed tariff measures in the United States for 2025 have introduced significant uncertainties across the biopharmaceutical supply chain. A survey by the Biotechnology Innovation Organization shows that nearly 90% of U.S. biotech companies depend on imported components for at least half of their FDA-approved products, and an overwhelming 94% anticipate notable increases in manufacturing costs should tariffs be enacted on imports from the European Union. Further, half of those surveyed indicated they would need to seek new research and manufacturing partnerships if tariffs were imposed, while 80% estimated at least 12 months to identify alternative suppliers-a timeframe that could imperil clinical and commercial milestones.

In response, leading biopharmaceutical companies are proactively fortifying domestic production. On July 21, 2025, Biogen announced a $2 billion expansion of its North Carolina manufacturing footprint, focusing on gene-targeting therapies and advanced fill-finish operations to mitigate potential tariff impacts. Similarly, industry leaders such as Roche and Novartis have pledged multibillion-dollar investments in U.S. facilities to align supply resilience with strategic onshoring objectives �usiness reliance on Chinese biotech advances underscores the high stakes: one-third of recent licensing deals by value trace back to China, highlighting the interplay between global innovation and domestic policy pressures.

Analysis of market segmentation reveals nuanced adoption patterns that underscore the value of tailored strategies for each stakeholder. Within therapy modalities, cell therapy approaches have seen rapid advances in manufacturing automation and regulatory approvals for autologous constructs, while gene therapy modalities are unlocking in vivo correction of genetic disorders and expanding into novel tissues. Patient demographics further stratify opportunity: adult populations benefit from established workflows and reimbursement pathways, geriatric cohorts demand specialized safety considerations and comorbidity management, and pediatric patients, though fewer in number, represent a highly receptive group for early-intervention strategies and long-term outcome studies.

Therapeutic areas illustrate the breadth of application, with oncology and hematology leading investment and clinical momentum, followed by immunology, metabolic disorders, neurology, and an emerging focus on rare diseases where catalyzing first-in-class approvals can reshape disease management. End users reflect diverse stakeholder needs: biopharmaceutical companies drive upstream innovation and licensing strategies; hospitals and clinics spearhead treatment center accreditation and patient access programs; and research institutions foster translational breakthroughs that feed the clinical pipeline. Collectively, these segmentation insights highlight the critical interplay between modality, patient profile, disease focus, and delivery channel, guiding resource allocation and partnership models for maximum impact.

Regional dynamics play an instrumental role in shaping commercialization and development strategies. In the Americas, the United States serves as a global hub for innovation, supported by a robust pipeline that accounts for 45% of all gene therapy trials, cutting-edge manufacturing infrastructure, and an expansive venture funding landscape. Latin American markets, while nascent, are attracting interest through public–private partnerships aimed at establishing local manufacturing and regulatory harmonization.

Europe, the Middle East, and Africa feature a mosaic of regulatory environments, with the European Medicines Agency driving centralized approvals and localized centers of excellence in the UK, Germany, and France. Collaborative frameworks under Horizon Europe and regional investment incentives are bolstering cross-border clinical consortia. In the Asia-Pacific region, China’s biotech ecosystem is maturing rapidly, with domestic companies forging international licensing deals and government policies incentivizing biologics production. Japan and South Korea continue to refine expedited review pathways and patient access programs, fostering a competitive environment for innovative cell and gene therapies.

Industry leaders and emerging innovators alike are driving competitive dynamics through differentiated pipelines, strategic collaborations, and novel platforms. Large pharma companies such as Pfizer, Roche, and AstraZeneca are diversifying their portfolios through high-value licensing agreements and acquisition of specialized biotech assets, reinforcing their positions across multiple therapeutic segments. Biogen, following its North Carolina investment, is assembling an ecosystem of CDMOs, automation providers, and AI-driven analytics to accelerate cell therapy scale-up and optimize yield.

At the vanguard of innovation, companies like Abeona Therapeutics and Neurotech Pharmaceuticals have secured approvals for therapies targeting RDEB and MacTel, respectively, showcasing the viability of both autologous and allogeneic modalities. Capricor Therapeutics and Fate Therapeutics exemplify cutting-edge development models, with Deramiocel accepted for priority review in DMD-associated cardiomyopathy and FT819 obtaining RMAT designation for lupus, underscoring the industry’s broadening focus on rare and autoimmune disorders.

Industry leaders must take decisive actions to capitalize on emerging opportunities while mitigating evolving risks. First, companies should diversify supply chains by qualifying multiple CDMO and raw material partners, ensuring continuity in the face of tariff-driven disruptions and supplier concentration. Leveraging automation, AI, and single-use technologies can bolster resilience and drive manufacturing efficiency, as exemplified by Cellares’ automated Cell Shuttle platform.

Second, proactive regulatory engagement will be critical. Sponsors should pursue RMAT and other expedited designations early in development, aligning clinical protocols with agency expectations to shorten review cycles and secure conditional pathways. The FDA’s recent removal of REMS requirements for CAR-T therapies highlights the value of robust safety data and collaborative risk‐management strategies.

Finally, investment in regional manufacturing and strategic alliances will ensure market responsiveness. Firms should consider targeted onshoring investments in key geographies, guided by political and economic incentives, while pursuing tiered pricing and patient assistance programs to optimize global access. This multifaceted approach will enable sustained innovation, competitive differentiation, and patient-centric outcomes in the cell and gene therapy landscape.

This report employs a rigorous multi-phase research framework to ensure the validity and comprehensiveness of its insights. Primary data collection included in-depth interviews with more than 20 senior executives, KOLs, and regulatory experts spanning biopharmaceutical companies, research institutions, and patient advocacy groups, providing firsthand perspectives on development challenges and strategic priorities.

Secondary research encompassed a detailed review of regulatory announcements and databases, including FDA press releases, RMAT designation records, and REMS policy updates. Clinical pipeline and trial data were sourced from industry intelligence providers and public registries to capture dynamic shifts in modality, therapeutic area, and geographic distribution. Additionally, a comprehensive survey of BIO members was analyzed to quantify the impact of U.S. tariff proposals on supply chains and innovation pathways.

Quantitative analysis integrated these data points with market segmentation and regional metrics to build a cohesive narrative, enabling robust validation of trends and supporting actionable recommendations. This dual-methodology approach guarantees a balanced view, combining qualitative depth with empirical rigor.

As the cell and gene therapy field continues its rapid ascent, it is clear that personalized modalities are on the cusp of transforming patient care across a spectrum of serious and rare diseases. Ongoing regulatory enhancements, such as REMS relaxation for CAR-T products and a growing number of RMAT designations, are lowering barriers to market and accelerating the pace of innovation. In tandem, a robust pipeline exceeding 2,000 gene therapies and hundreds of cell therapy trials underscores the breadth of scientific ingenuity and the readiness of the industry to deliver breakthrough treatments at scale

To unlock the full depth of analysis on personalized cell and gene therapies, reach out to Ketan Rohom, Associate Director, Sales & Marketing. Direct engagement with Ketan Rohom will provide you with immediate access to the comprehensive market research report, featuring the latest regulatory developments, segmentation insights, regional analyses, and actionable recommendations. Secure your competitive advantage today by connecting with an expert who can guide you through the report’s key findings and facilitate a seamless purchasing experience.